VYAIRE MEDICAL, INC ELECTRODES, FETAL SCALP (FSE), 50/CASE; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
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Catalog Number 7000AAO |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
Pregnancy (3193)
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Event Date 11/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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No sample was provided for evaluation.If a sample or any additional information becomes available a follow up submission will be filed.
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Event Description
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The scalp electrodes are not coming off the baby's head prior to delivery.When the physicians or nursing staff have gone to remove the fetal scalp electrodes from the infants head it would not unscrew.They cut the pink and blue cord, separate the cords as instructed, which is suppose to unscrew the electrode.In the case where it would not come off the fetal scalp we have had to cut the cords very short and deliver the baby via cesarean section and remove the scalp electrodes from the baby's head.This puts the mom at a greater risk for infection since we are bringing the cords through the vagina into the uterus.The physicians are the ones who place the fetal scalp electrodes on the infants head.The cords involved have all been disposed of, because they were used.
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Search Alerts/Recalls
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